10 ago - Italia
The Medical Affairs
Territory includes but not limited to: All of EU countries as needed Duties and Responsibilities Site engagement and training A cadence of touchpoints with sites on a regular basis Meeting with sites and presenting at PSVs, SIVs Retraining as needed (e.g., due to amendments) Recruitment issues Site identification/recruitment: Meeting with potential sites, in collaboration with CTL, to discuss the program/assess of their interest Patient recruitment issues (ongoing oversight): Meeting with sites, in collaboration with CTL, to help understand the hurdles with recruitment at their site and trouble shooting Answering questions from sites Helping address site medical/clinical questions as a first line for those questions that are straightforward or previously addressed or to help coordinate a response with the Medical Director for those that are not straightforward/new This includes referencing and updating the FAQ,
as applicable Medical Director should always be copied on the email correspondence for oversight Assisting with eligibility assessments Help perform eligibility checks or address urgent eligibility questions prior to randomization Assisting with query closure Helping site understand what is needed to close a medical query if there is a misunderstanding from the site regarding what is needed Feedback should also be provided to the study team if the query text could be improved for clarity Helping ensure that the information that we must have to describe a safety event is sufficient, including: Ensuring that all information has been gathered as expected (i.e., the site has taken all reasonable steps to obtain the information, etc.) in collaboration with the CRA, if additional support is needed during escalation process Ensure that all questions have been answered/follow-up assessments have been done This may include requesting additional assessments for a complete evaluation/specialist consultation, etc. Protocol Deviations In collaboration with the CTL, retrai
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